Medical Device Manufacturer · US , Mchenry , IL

Parkell, Inc. - FDA 510(k) Cleared Devices

53 submissions · 53 cleared · Since 1976
53
Total
53
Cleared
0
Denied

Parkell, Inc. has 53 FDA 510(k) cleared dental devices. Based in Mchenry, US.

Latest FDA clearance: Aug 2025. Active since 1976.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

53 devices
1–12 of 53
Parkell Pit and Fissure Sealant
K243254 · EBC Sealant, Pit And Fissure, And Conditioner · Dental
Aug 2025 297d
Parkell Self-Adhesive Cement
K210259 · EMA Cement, Dental · Dental
Jan 2022 353d
Parkell Desensitizer Gel
K191103 · EJK Liner, Cavity, Calcium Hydroxide · Dental
Nov 2019 211d
SmarTemp X1
K190930 · EBG Crown And Bridge, Temporary, Resin · Dental
Sep 2019 148d
HyperFil-LV
K182296 · EBF Material, Tooth Shade, Resin · Dental
Dec 2018 112d
Parkell Universal Adhesive
K172176 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2017 125d
BRUSH&BOND PLUS
K151518 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2015 105d
EAZY PRIMER
K142848 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2015 147d
ABSOLUTE DENTIN 2
K132115 · EBF Material, Tooth Shade, Resin · Dental
Jun 2014 351d
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · MVL Cord, Retraction · Dental
Apr 2012 106d
RETRIEVE IMPLANT CEMENT
K101044 · EMA Cement, Dental · Dental
Jun 2010 57d
DURAFINISH ALL-CURE, MODEL S296
K080549 · EBD Coating, Filling Material, Resin · Dental
May 2008 76d

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